Status:
COMPLETED
Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis
Lead Sponsor:
Sun Yat-sen University
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
To assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients w...
Detailed Description
This is a 4-week randomized, open-label trial to investigate the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosin...
Eligibility Criteria
Inclusion
- 18 to 65 years
- Meet 1984 modified New York criteria for AS
- The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3
- NSAIDs washout period of at least 5 days prior to randomization
- DMARDs washout period of at least 4 weeks prior to randomization
- Corticosteroids washout period of at least 4 weeks prior to randomization
- Biological agents washout period of at least 3 months prior to randomization.
Exclusion
- Peptic ulcer
- Unstable cardiac diseases
- Abnormal hepatic function with an elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 times of upper normal limits
- Abnormal renal function with creatinine more than upper normal limit
- Hematologic disorders
- Psychosis
- Malignancy
- Allergic to LX drug.
Key Trial Info
Start Date :
May 25 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03800797
Start Date
May 25 2015
End Date
December 10 2015
Last Update
January 11 2019
Active Locations (1)
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1
Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China